Poor compliance with the physician-prescribed medication regimen is a major cause of disease-related morbidity and mortality. For example, hypertension, which affects 60 million Americans, is a significant risk factor for stroke, heart and kidney diseases. Research has demonstrated that hypertension can be controlled in the vast majority of patients with currently available medications if patients adhere to the prescribed regimen at least 80% of the time. Unfortunately, many patients are not compliant with their medications and therefore are at increased risk of complicating illnesses. The lack of a satisfactory method of measuring medication compliance has hindered the assessment of attempts to improve compliance as well as research which might increase our understanding of poor compliance.
Various previously proposed devices for testing compliance of patients with prescribed medication regimens have proven to be unsatisfactory in that they are relatively cumbersome, are not accurate, and do not adequately cover the extended time spans for which many prescribed dosing regimens must be maintained.
In general, the prior art includes a number of mechanical devices for indicating the timed removal of pills from various holders or dispensers. For example, the Fortenberry U.S. Pat. No. 3,410,450 discloses a sanitary pill dispenser with an indicator dial to indicate release of each successive pill. Also see the Bender U.S. Pat. No. 3,871,551 which shows a pill dispenser with a pill-actuated time readout. Barton et al U.S. Pat. No. 3,402,850 discloses a tablet dispenser with a day-indicating schedule.
The patent to Gervais U.S. Pat. No. 3,344,951 shows an injection pill dispenser which incorporates a mechanical device for recording of times of pill removal under prescribed conditions. The Pilot U.S. Pat. No. 3,332,575 shows another dispenser with an indicating means, which indicator gives the day each pill is dispensed. Harman et al U.S. Pat. No. 3,688,945 shows another mechanical tablet dispenser, for contraceptive pills, with a time indicator. The Gayle U.S. Pat. No. 3,687,336 shows another mechanical device which ejects pills in synchronization with day indicating means. And Huck U.S. Pat. No. 3,511,409 shows another mechanical dispenser with a day indicator for pill usage.
Accordingly, there is a definite need for an improved device for measuring the compliance of patients with physician-prescribed medication regimens.